The present invention relates generally to an intraluminal radiation system for the delivery of treatment elements by way of a catheter to a selected location within the intraluminal passageways of a patient. More particularly, the present invention relates primarily to an improved transfer device for handling the treatment elements and delivering them to the catheter.
Since the late 1970's balloon angioplasty techniques have become widely used for opening blockages in coronary arteries. Briefly, the enlargement of the artery is achieved by advancing a balloon catheter into a narrowed portion of the artery and inflating the balloon to expand the diameter of the artery, thus opening the artery for greater blood flow. Atherectomy techniques, in which blockages are removed or reduced in size, have also been used to the same end.
While balloon angioplasty has proved an effective way of opening the coronary arteries, in a significant number of cases the arteries narrow again at the location where the balloon was expanded, such narrowing being termed restenosis. Restenosis is believed to be caused by formation of scar tissue at the site of the angioplasty that results from the injury to the artery caused by the inflation of the balloon. More recently, intraluminal radiation has been used after angioplasty or atherectomy to treat the affected area of the artery to inhibit cell proliferation and wound healing response and, consequently, help to prevent restenosis. Methods and apparatus for such intraluminal radiation treatment are disclosed in U.S. Pat. Nos. 5,899,882 and 6,013,020, and co-pending applications Ser. No. 09/304,752, filed May 4, 1999, and Ser. No. 09/469,510, filed Dec. 22, 1999, all of which are incorporated herein by reference. These applications generally disclose an apparatus comprising a catheter, which is inserted intraluminally into the patient and advanced to the site of the area to be treated, and a transfer device for facilitating either the hydraulic or pneumatic advancement and retrieval of individual radioactive treating elements or “seeds” along the catheter to and from the treatment site. A plurality of treatment elements comprises a “source train.”
As with any device inserted into the vascular system, it must have sufficient integrity to insure that no pieces or elements are separated from or exit the device into the vascular system. This is particularly true for the treating elements which are moved to and from the distal end of the catheter. Additionally, because the device is intended to use radioactive treating elements, there is a heightened need for safety to prevent any unintended exposure of either the patient or the user to radioactivity.
Actual use of the apparatus described in the above-identified patents and co-pending applications has suggested several areas where the device could be improved to reduce the possibility of having treatment elements escape from the system, thus enhancing patient and user safety.
Consequently, it is the principal object of the present invention to provide a transfer device and catheter assembly that has additional safeguards to protect the patient and user for unintended exposure to radiation.
More particularly, it is an object of the present invention to provide a transfer device/catheter assembly in which the treatment elements cannot be inadvertently released from the transfer device.
Additionally, it is an object of the present invention to provide a transfer device capable of advancing and retrieving source trains of varying lengths for treatment of different sized lesions. More particularly, the transfer device is adapted to receive interchangeable cartridges which house source trains of varying lengths.
Another object of the present invention is to provide a delivery system that requires both automation and manual manipulation to successfully and safely advance the user through the treatment procedure. More particularly, the transfer device automatically creates the pressurized fluid flow, senses the presence or absence of the treating elements within the transfer device, and permits or prevents movement of the gate mechanism to the open or closed position through the use of electromechanical means and prompts the user to sequentially follow the appropriate manual steps for safely providing treatment to the patient.